The present invention generally relates to compositions and methods for the improved detection and classification of neoplasms such as malignancies, preferably using specific binding reagents, such as antibodies.
The ability to accurately diagnose neoplasms, including the ability to differentiate between benign and malignant cells, is central to the successful treatment and subsequent survivability and quality of life of those fallen victim to cancer. The penalty for error in such diagnosis is high for the patient. For example, if a malignant growth is improperly diagnosed as benign, then the patient has poor prognosis compared to patients accurately diagnosed and correctly treated. Furthermore, if a benign growth is diagnosed as malignant, then the patent may be subjected to unnecessary and costly treatments that themselves can be life threatening. Current preferred methods of diagnosis of neoplasia rests on visual observation of samples of tissues, fluids or tumors taken from a patent. The samples can be prepared in a variety of ways, including histochemical staining with a variety of reagents, which assist a pathologist in determining, morphological, cellular and/or tissue structures and appearances upon observation with a microscope. However, such methods tend to be imperfect because several types of neoplasms have similar morphological cellular and/or tissue structures. Thus, there exists a need for systems, compositions and methods that would assist medical professionals in diagnosing neoplasms.
Although not normally visible through a light microscope typically used by a pathologist, neoplastic cells comprise biomolecules, such as proteins, that differ in the type and/or amount relative to the related normal cell. This difference can be exploited to develop specific and accurate tests to identify such neoplastic cells. The present invention provides systems, methods and compositions that allow neoplasms to be differentiated based on the type and level of expression of transcription factors present within a cell. These methods are complementary to existing morphological approaches and provide greatly improved reliability and accuracy. By making the diagnosis of neoplasms a less subjective endeavor, the present invention provides great benefits to the field of medicine, in particular, but not limited to, pathology, oncology and pharmacology.